From The Editor | February 4, 2021

Novartis Manufacturing For Pfizer: It's Not Unusual


By Louis Garguilo, Chief Editor, Outsourced Pharma


Breaking news: This isn’t quite the breaking news it’s been made out to be.

It sure is good news.

And the attention it’s getting is deserved and understandable.

Did I say attention? An internet search of Novartis+Pfizer+Vaccine returned 2.85 million hits.

In case you somehow hadn’t heard, Novartis will take up some of the COVID-19 Pfizer/BioNTech vaccine production into one of its own facilities, in Stein, Switzerland.

However, to be clear:

Big Pharma manufacturing for other pharma is not news.

It happens more often than it appears people realize – even those in our own industry.

As the current headlines were marching through news feeds and outlets, I reached out to our network to confirm what I had learned years ago.

Just shy of a dozen current and former Big Pharma and other biopharma executives replied immediately. Among other examples, they mentioned other name-brand organizations such as Merck, Amgen, Genetech, who have had drugs contract-manufactured at other (potential competitor and non-CMO) pharma companies.

Hinting at the relatively easy decision to do this – outsource to another pharma – I received this reply from a Big Pharma executive (smiley included):

“Supply and demand for mutual benefit. :-)”

Mutually beneficial – and certainly to the great benefit of patients and governments worldwide in this case.

More Smiles Of Recognition

Another of my interlocutors with decades of experience provided this noteworthy example:

“In 2011, when Merck suddenly found themselves needing capacity for Keytruda, they took in a non-CMO relationship to aid in production. The partner produced two batches a year in a 4x15k plant, capable of 64 batches. Obviously, both parties needed each other.”

This reply ended with: “Not unprecedented at all, or unexpected especially given the pandemic.”

A third experienced executive wrote:

“If you have a blockbuster particularly, you source wherever you can.  When Amgen hit it big with Embrel, they had four large DS [drug substance] manufacturing sites – including one at Genentech! 

“When your internal capacity is constrained, and you don’t have many options in the CMO space, you talk to companies that may have capacity to support your supply chain. 

“I have worked personally with more than one large pharma company as a client, and we as the “CMO.”  

The CEO of a vaccine company offered this specific to the industry we’re all currently focused on:

“We’ve had examples when competitive companies have stepped in to produce additional flu vaccines due to manufacturing problems occurring with competitors.”

He added:  

“While it’s not unprecedented, this current example does demonstrate that, regardless of our highly competitive commitments, our industry is ultimately focused on ensuring appropriate access and distribution to those in need.”

Shoe On The Other Foot

In our current case, Novartis has stepped in to support Pfizer/BioNTech.

But it has been the other way around for Pfizer.

A former manufacturing executive there said:

“This is not unusual. As you may know, in the past Pfizer itself has sought to utilize excess capacity and technical expertise to help several [other pharma] companies bring their products to market.  

“Better to plug a new product into a proven system, than hand it over to one untested by time. It helps de-risk the product’s launch and initial supply.”

She added:

“Perhaps it's the size of the two companies partnering in this Novartis-Pfizer case that is more unusual; or the magnitude of the deliverable needed globally.  

“Nonetheless, I recall several times doing business with top pharma, more typically on a smaller, novel product at introduction, and usually leveraging a technology the client company did not yet possess.  

“These are strategic business decisions, executed perhaps at a more tactical operations scale.  

“While this COVID-19 vaccine example is larger, and taken for the sheer benefit of maximizing throughput as quickly as possible, different drivers come into play. But the same results of utilizing the best available resources to meet a business (and in this case societal) need are the same.

“I also sense that the mission, and cultural philosophies of Pfizer/BioNtech and Novartis are well aligned, making a partnership possible in a short-enough time to meet the required need.”

Another Pfizer executive added to this:

“It is not unprecedented for Novartis to offer up their DP manufacturing capacity to Pfizer (actually, specifically to BioNTech). But this pandemic has definitely brought drug sponsors together in unity, pledging even to share data, as in this case.”

Any Concerns?

Ah, yeah:

IP. Trade Secrets. Contracts, economics, tech transfer, competitive advantage, etc.

A consultant with years of experience knows this “cross-manufacturing” would happen much more if it weren’t for certain IP and trade-secret concerns and laws.

Specifically, he said, “because of some Supreme Court decisions regarding the ability to patent molecules naturally occurring in the body, many biotechs rely heavily on Trade Secrets as a fall back to IP protection.”

However, he continues, “recently the Department of Justice have relaxed IP and Trade Secret laws for COVID, to allow for this greater level of collaboration.”  

“So folks like Novartis can jump in to help, with less of a specter of litigation or other potential challenges in the future.”

“The willingness to explore ways to get things done together has always been present in our industry at the highest levels, but the routine application of these practices is far less frequent than they could be.”

A final note as we close:

This type of contract manufacturing among rivals holds up across industries.

One prime example:

Bitter rival Samsung, maker of Galaxy smartphones, produces components for Apple, maker of the iPhone.

Still, while that is an important relationship for consumers, it certainly does not compare with the potential importance of our industry’s collaborations.

As another responder wrote me:

“While the collaborative support demonstrated by seemingly competitors isn’t unprecedented, such collaboration, focused on ensuring ample supply of COVID-19 vaccine, deserves accolades and recognition of our industry.”

And the entire world.

And who knows: Perhaps some readers will include fellow biopharma in the search for your next “CDMO.”

That would be news.